Safety Clinical Trial
Official title:
A Multiple Dose, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Topically Administered CT327 in Healthy Male Volunteers
K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to
inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes
freely into the cell membranes of keratinocytes and accumulates at a systemic level. In
order to reduce the dermal absorption and reduce the possible long-term systemic toxicity
this study will assess a PEGylated derivative of K-252a named CT327. This approach should
improve the safety profile of the K-252a molecule while maintaining its activity. The
primary objective is to assess the safety and tolerability of single and repeat doses of
CT327 when applied topically to the skin of healthy male volunteers.
The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics;
PK) of CT327 following single and repeat doses in healthy male subjects.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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